Regulatory Open Forum

As this group knows, the FDA's 2019 guidance on "General Wellness" is often used to assess whether a device should or should not be considered a medical device.   See https://www.fda.gov/media/90652/download.

My question to the community is this-  does anyone know whether Australia has an analogue to that guidance document, such that a manufacturer can assess whether their US regulatory/commercial approach should be adjusted for Australia?


Roger

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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
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Hello Roger

Changes to the regulation of software based medical devices came into effect in Australia from 25 February 2021. Greater clarity was introduced also in relation to types of products covered by the FDA guideline.

You can find all the details here: Regulation of software based medical devices | Therapeutic Goods Administration (TGA).

Hope it helps.

Karen

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Karen Smith
Regulatory Affairs Project Manager
Macquarie Park NSW
Australia
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Original Message:
Sent: 04-Aug-2022 16:58
From: Roger Cepeda
Subject: Australian "General Wellness" guideline for devices?

As this group knows, the FDA's 2019 guidance on "General Wellness" is often used to assess whether a device should or should not be considered a medical device.   See https://www.fda.gov/media/90652/download.

My question to the community is this-  does anyone know whether Australia has an analogue to that guidance document, such that a manufacturer can assess whether their US regulatory/commercial approach should be adjusted for Australia?


Roger

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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
------------------------------